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Regulating GM Foods A Comparison of Approaches by odl20037

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									   Regulating GM Foods:
A Comparison of Approaches

         Economic Consideration of Biosafety and
         Biotechnology Regulations in India: A
         Policy Dialogue

         IFPRI & RIS
         August 24-25, 2006
                                                             2

    Food safety
●   Food safety refers to the potential hazards associated
    with food that can cause ill-health in humans

●   Potential hazards (WHO):
     1.  Microbial pathogens
     2.  Zoonotic diseases
     3.  Parasitic organisms
     4.  Physical contaminants and adulterants
     5.  Naturally-occurring toxicants
     6.  Agro-chemical and veterinary drug residues
     7.  Prions
     8.  Persistent organic pollutants
     9.  Heavy metals
     10. Genetically-modified organisms that may contain
         allergens or toxins that are not found in
         conventional foods
                                                     3

     Regulation and safety assessment
●   In the early 1990s, the impending introduction
    of GM products into agriculture and food
    prompted countries to create regulatory
    frameworks specifically targeted to these
    products

●   Strong regulatory framework would protect
    health and safety, provide a predictable
    environment for public and private sector
    product developers, and build consumer
    confidence

●   Rethink our traditional view of food safety –
    develop systematic approaches to evaluation
                                        4

Countries that have approved GM foods

 Argentina        Netherlands
 Australia        Philippines
 Brazil           Russia
 Canada           South Africa
 China            Switzerland
 Czech Republic   Taiwan
 EU               UK
 Japan            US
 Korea            Uruguay
 Mexico
                                   5

Comparison of regulatory systems

 Argentina        Netherlands
 Australia        Philippines
 Brazil           Russia
 Canada           South Africa
 China            Switzerland
 Czech Republic   Taiwan
 EU               UK
 Japan            US
 Korea            Uruguay
 Mexico
                  +India
                                                               6

         Who are the competent authorities?

Country                              Authority
                Food safety               GM Foods
Argentina       SENASA                    SENASA
Australia       FSANZ                     FSANZ
China           Ministry of Health        Ministry of Health
Canada          Health Canada             Health Canada
EU              EFSA                      EFSA
India           MoH&FW                    MoEF
Japan           MoHL&W                    MoHL&W
South Africa    Dept. of Health           Dept. of Health
US              FDA                       FDA
                                                                                                          7

      Implementing GM food regulations




                                                                                      South Africa
                        Argentina

                                    Australia
                                                Canada




                                                                              Japan
                                                         China


                                                                      India
                                                                 EU




                                                                                                     US
Voluntary guidelines
                                                                                                     X

Statutory instruments
                           X         X           X        X      X     X       X        X
                                                                                                                  8

         Existing vs. new legislation




                                                                                              South Africa
                                Argentina

                                            Australia
                                                        Canada




                                                                                      Japan
                                                                 China


                                                                              India
                                                                         EU




                                                                                                             US
Existing legislation amended
                                   X         X           X        X            X                X            X

New legislation to
specifically address GM foods                                            X             X
                                                      9

     Safety assessment
●   Regardless of the different approaches taken to
    implement biosafety legislation and
    regulations, there has been a remarkably
    consistent approach to assessing safety

●   This has been a result of more than a decade of
    international consultation
     FAO
     WHO
     FAO/WHO Expert Consultation on GM Foods
     International Life Science Institute
     OECD
     International Food Biotechnology Council
     CODEX
                                                                                                                 10

         Safety assessment




                                                                                             South Africa
                               Argentina

                                           Australia
                                                       Canada




                                                                                     Japan
                                                                China


                                                                             India
                                                                        EU




                                                                                                            US
Safety assessment by an
expert committee                  X                              X      X     X                X

Safety assessment carried
out by evaluators within the                X           X                             X                     X
public service
                                                                                                                  11

         Safety assessment of food and/or feeds




                                                                                              South Africa
                                Argentina

                                            Australia
                                                        Canada




                                                                                      Japan
                                                                 China


                                                                              India
                                                                         EU




                                                                                                             US
GM food and GM feed
assessed separately                                      X                             X

“Safe for food, then safe for
feed”                              X         X                    X      X     X                             X
                                                                                                                  12

          Decision making




                                                                                              South Africa
                                Argentina

                                            Australia
                                                        Canada




                                                                                      Japan
                                                                 China


                                                                              India
                                                                         EU




                                                                                                             US
Decision primarily based on
science                                      X           X        X            X       X                     X

Decision also includes social
and/or economic factors            X                                     X                      X
                                                                                                                     13

           Public participation & transparency in decision making




                                                                                                 South Africa
                                   Argentina

                                               Australia
                                                           Canada




                                                                                         Japan
                                                                    China


                                                                                 India
                                                                            EU




                                                                                                                US
Mandatory requirement for
public notification of decisions                 X                          X                                   X

No legal requirement for
notification                          X                     X        X            X       X        X

Mandatory requirement for
public comment prior to                          X                          X                      X            X
decisions
No legal requirement for public
comment prior to decisions            X                     X        X            X       X



Internationally, the trend is to increasing transparency
                                                                                                               14

         Post-release monitoring of GM foods




                                                                                           South Africa
                             Argentina

                                         Australia
                                                     Canada




                                                                                   Japan
                                                              China


                                                                           India
                                                                      EU




                                                                                                          US
None or “ongoing duty of
care” on part of developer      X         X           X               X     ?       X        X            X

Mandatory
                                                               X
                                                                                                                 15

         Detection method required




                                                                                             South Africa
                               Argentina

                                           Australia
                                                       Canada




                                                                                     Japan
                                                                China


                                                                             India
                                                                        EU




                                                                                                            US
Event specific detection
method for GM plant or                      X          X1        X      X
derived product required
Detection method not
required                          X                                           X       X        X            X



 1Required   for GM plants but not GM foods
                                                                                                                16

         Labelling of GM foods




                                                                                            South Africa
                              Argentina

                                          Australia
                                                      Canada




                                                                                    Japan
                                                               China


                                                                            India
                                                                       EU




                                                                                                           US
Mandatory labelling
                                           X                    X      X     P       X

Voluntary standards/
                                 X                     X                                      X            X
no GM specific guidance1

1Labellingis required for all foods, including GM foods, when
there have been significant changes in nutritional properties or
presence of an allergen.
                                                      17

    Concluding comments

●To date, there is no single regulatory system that
can be held up as the “best” model for addressing
GM foods.
●Different approaches can, and have, been used

effectively.
●Regulatory system for GM foods should be

adaptable, responsive and consistent.
●It is essential to ensure that any system designed

to regulate GM foods be coherent with, and a part
of, existing regulatory programs for food safety.

								
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